Myocardial Infarction
Conditions
Keywords
STEMI, myocardial infarction, stent
Brief summary
The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).
Interventions
DEVICEMGuard
MGuard™ stent comprises a balloon-expandable, thin-strut stainless steel (316L) bare metal stent platform (strut width 100 µm) with mesh sleeve fibers of polyethyleneterephtalate (fiber width of 20 µm) attached to its outer surface. These fibers act like a net (aperture size 150 x 180 µm) preventing distal embolization of the plaque debris/thrombus placed between the vessel wall and the stent.
DEVICEControl BMS or DES
Control BMS or DES
Sponsors
InspireMD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age * ST-segment elevation (more than 2mm in more than contiguous leads) * MI with symptom onset less than 12h * The patient is willing to comply with specified follow-up evaluations * Signed ICF * Single de novo lesion in the target (culprit) vessel * Target lesion maximum length is 33 mm (by visual estimation) * Reference vessel diameter must be more than 3.0 to less than 4.0 mm by visual estimation * Randomization should occur as soon as Presence of TIMI 2 or 3 before randomization
Exclusion criteria
* Pregnant or nursing patients * Left Bundle Branch Block (LBBB), paced rhythm, or other Electrocardiogram (ECG) abnormality * Impaired renal function * Prior coronary artery bypass graft surgery * Bleeding diathesis * Contraindication to aspirin * cardiopulmonary resuscitation * Cardiogenic shock * chronic warfarin anticoagulation * LVEF less than 20% * other medical illness * participation in another investigational drug or device study that has not reached its primary endpoint * Left main coronary artery disease with 50% stenosis * Ostial target lesion * Failure to visualize vessel anatomy distal to the culprit lesion * Moderate to heavily calcified target lesion or vessel * excessive tortuosity * bifurcation with a side branch more than 2.0 mm in diameter * A significant (greater than 50%) stenosis proximal or distal to the target lesion is present that cannot be covered by same single stent * Diffuse disease distal to target lesion with impaired runoff * Any prior stent proximal to the target lesion, or within 10 mm distal of the target lesion * PCI of another lesion performed within 6 months before the index procedure * Target lesion located in a saphenous vein graft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution | 60 to 90 minutes after the last angiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure. | 60-90 minutes after last angiogram | The incidence of TIMI 3 flow at the end of the procedure. |
| Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure | discharge, 30 days, 6 and 12 months post-procedure | Major Adverse Cardiac Events (MACE): defined as cardiac death, reinfarction (Q wave and non-Q wave), or repeat ischemia-driven target lesion revascularization (TLR) by percutaneous or surgical methods at hospital discharge, 30 days, 6 months and 1 year post-procedure. |
Countries
Poland, South Africa
Outcome results
None listed